Effect of Vestibular Stimulation on Fat Consumption and Energy Expenditure as Assessed Using Indirect Calorimetry

NCT03138382 | Completed Results FDA Device

• 1 other identifier: 170798
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is an ongoing and worsening problem with obesity in the developed, and much of the developing world. Although it has long been realized that Western diets that are rich in sugar and fat play an important role in this, it has only recently been realized that exposure to these diets, particularly in childhood, can damage the part of the brain that determines how much fat there is in the body. The result of this damage is that the so-called "set-point" for fat in this part of the brain is pushed upwards. There is a lot of evidence from animals that activating the brain's balance (vestibular) system pushes this set-point for fat downwards to cause fat loss, probably because this "tricks" the brain into thinking that there is increased physical activity. The aim of this study is to see whether non-invasive electrical stimulation of the vestibular system in human participants causes a change in metabolism of fat and/or energy expenditure, which, if regulated upwards, would suggest this could be used as a means of reducing body fat in humans.

Conditions

Obesity; Metabolic Syndrome

Keywords

obesity; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Fat Consumption (During VeNS)

  Change in percent fat utilization from baseline as measured using indirect calorimetry.

  During middle 15 minutes of 45 minute vestibular nerve stimulation session

Secondary Outcomes (1)

• Change in Energy Expenditure (During VeNS)

  During middle 15 minutes of 45 minute vestibular nerve stimulation session

Study Arms (2)

Treatment then sham

EXPERIMENTAL

20 subjects will be randomised to first receive active vestibular nerve stimulation during indirect calorimetry. Then 2 weeks later they will return for sham stimulation during indirect calorimetry.

Device: Vestibular Nerve Stimulator; Device: Sham stimulator

Sham then treatment

EXPERIMENTAL

20 subjects will be randomised to first receive sham stimulation during indirect calorimetry. Then 2 weeks later they will return for active vestibular nerve stimulation during indirect calorimetry.

Device: Vestibular Nerve Stimulator; Device: Sham stimulator

Interventions

Vestibular Nerve Stimulator DEVICE

Electrical stimulation of the vestibular nerve with vestibular nerve stimulator (GVS device) for for 45 minutes using binaural mastoid placement.

Sham then treatment; Treatment then sham

Sham stimulator DEVICE

Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.

Sham then treatment; Treatment then sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Body mass index (BMI) \> 25 kg/m2
• years of age inclusive on starting the study.
• Successfully completed the screening questionnaire.

You may not qualify if:

• History of vestibular dysfunction.
• History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
• History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
• Positive response in Physical Activity Readiness Questionnaire.
• Currently taking medication for asthma or other breathing conditions.
• Untreated thyroid disorder (stable treatment for 3 months is acceptable).
• Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
• Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
• History of cirrhosis, or liver, kidney or heart failure.
• Chronic pancreatitis.
• Treatment with prescription weight-loss drug therapy in the year before starting the study.
• Tobacco or marijuana smoking in the 6 months prior to study.
• Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
• Diabetes mellitus (Types 1 \& 2).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Results Point of Contact

• Title: Dr Paul McGeoch
• Organization: UCSD

pdmcgeoch@ucsd.edu

858-232-3312

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * Crossover design * Double-blind * Randomized

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 3, 2017
• Study Start: August 25, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 27, 2019
• Results First Posted: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)